Benazepril Hydrochloride, Lisinopril, Ramipril, or Losartan Potassium in Treating Hypertension in Patients With Solid Tumors

Hypertension Clinical Trial

Official title:

A Phase II Study of the Effect of ACE Inhibitors on Pro-Angiogenic Hormones in Cancer Patients With Hypertension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01234922
• Other study ID #: IRB00014933
• Secondary ID: NCI-2010-02043IR
• Status: Terminated
• Phase: Phase 2
• Start date: February 2011
• Est. completion date: April 2014

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Benazepril hydrochloride, lisinopril, ramipril, and losartan potassium may help lower blood pressure.

PURPOSE: This phase II trial is studying how well benazepril hydrochloride, lisinopril, ramipril, or losartan potassium works in treating hypertension in patients with solid tumors.

Description:

PRIMARY OBJECTIVES:

I. To determine which drug has the greatest effect on Ang-(1-7) levels in cancer patients with hypertension.

SECONDARY OBJECTIVES:

I. To determine the effect of these drugs on levels of Ang II, VEGF, PlGF, and ACE in the same patients.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

• ARM I: Patients receive oral benazepril hydrochloride once daily on days 1-7.

• ARM II: Patients receive oral lisinopril once daily on days 1-7.

• ARM III: Patients receive oral ramipril twice daily on days 1-7.

• ARM IV: Patients receive oral losartan potassium once daily on days 1-7. In all arms, treatment continues in the absence of unacceptable toxicity.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed solid tumor malignancy AND hypertension, defined as a systolic pressure > 130 OR a diastolic pressure > 80

• Patients cannot be on active chemotherapy or radiation therapy; start of treatment with ACE-I or ARB must occur at least four weeks after the last dose of chemotherapy or radiation therapy

• Creatinine < 2.5

• Potassium < ULN

• Ability to understand and the willingness to sign a written informed consent document

• HIV positive patients are eligible to participate in this study

Exclusion Criteria:

• Patients who are pregnant or nursing due to significant risk to the fetus/infant

• Patients who are unable to take oral medications

• Patients who are currently taking an ACE-Inhibitor or ARB

Related Conditions & MeSH terms

• Hypertension
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• lisinopril
Given orally
• losartan potassium
Given orally

Other:
• laboratory biomarker analysis
Correlative studies

Drug:
• benazepril hydrochloride
Given orally
• ramipril
Given orally

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter		7 days post-baseline
Secondary	Change in Ang II, VEGF, PlGF, and ACE Levels		1 week